Director/Senior Director, Regulatory AffairsInsmed

THIS JOB HAS EXPIRED

Reporting to the Vice President, Regulatory Affairs, this position will have overall responsibility for providing CMC Regulatory oversight & strategic technical regulatory input across all project activities to ensure CMC regulatory requirements/commitments are met with respect to approvals for new products.
Responsibilities:
Provide regulatory direction for the coordination, preparation and timely submission of CMC regulatory submissions consistent with corporate strategy & timelines
Formulate & implement CMC regulatory strategies and plans to achieve efficient & competitive product development
Act as regulatory lead for the review of CMC documentation prepared by other technical functions
Review & approve internal CMC documentation supporting product development activities e.g change controls, validation protocols etc.
Provide regulatory CMC input into project teams as required to provide technical guidance & to assist in problem solving/issue resolution etc.
Assist in CMC communications/negotiations with Regulatory Agencies
Act as primary FDA contact for general technical enquiries
Monitor the development of new CMC requirements or regulatory procedures
Assist QA as needed in Regulatory Authority facility inspections
Position Requirements:
10+ years of Pharmaceutical industrial experience with 5+ years of Regulatory CMC experience
Must have direct experience with managing initial NDA and MAA (eCTD) submissions, including submission writing and review experience. Experience with inhalation products would be a plus.
Must have experience of direct interactions & negotiations with Global Regulatory Agencies.
Must have extensive experience and knowledge of the entire global pharmaceutical development & approval process & associated regulations/guidelines
Strong interpersonal and written/verbal communication & influencing skills.
Excellent organizational, planning, and follow-up skills. Must have ability to meet tight deadlines and be efficient, detail-oriented, flexible, and a self-starter.
Excellent computer skills; MS Word and Adobe Acrobat are required. Experience with preparing submission-ready PDFs and use of Microsoft Excel highly desired.
Minimal travel may be required.
The following personal characteristics:
A bias towards action combined with high ethical standards.
A self-starter combined with a high energy level.
Education Requirements:
A bachelor?s degree in a relevant discipline is required. Advanced degree is preferred.